DK1276467T3 - Formulations and tablets for delayed release of guaifenesin - Google Patents

Formulations and tablets for delayed release of guaifenesin

Info

Publication number
DK1276467T3
DK1276467T3 DK01928870T DK01928870T DK1276467T3 DK 1276467 T3 DK1276467 T3 DK 1276467T3 DK 01928870 T DK01928870 T DK 01928870T DK 01928870 T DK01928870 T DK 01928870T DK 1276467 T3 DK1276467 T3 DK 1276467T3
Authority
DK
Denmark
Prior art keywords
guaifenesin
product
release formulation
modified release
total amount
Prior art date
Application number
DK01928870T
Other languages
Danish (da)
Inventor
Ralph W Blume
Donald J Keyser
Robert D Davis
Original Assignee
Adams Respiratory Therapeutics
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24233984&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1276467(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Adams Respiratory Therapeutics filed Critical Adams Respiratory Therapeutics
Application granted granted Critical
Publication of DK1276467T3 publication Critical patent/DK1276467T3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/075—Ethers or acetals
    • A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • A61K31/09—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon having two or more such linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/10—Expectorants

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention relates to a modified release pharmaceutical product having two portions, wherein a first portion comprises a first quantity of guaifenesin and a first pharmaceutical additive in an immediate release formulation, wherein the first quantity of guaifenesin becomes fully bioavailable in the subject's stomach, and a second portion comprises a second quantity of guaifenesin and a second pharmaceutical additive in a sustained release formulation, wherein the ratio of said first quantity to said second quantity provides a C max in a human subject equivalent to the C max obtained when the first of three doses of a standard immediate release formulation having one third of a total amount of guaifenesin in the modified release product is dosed every four hours over a 12 hour period, wherein said product also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis, and wherein the total amount of guaifenesin in the modified release product is from 600 mg to 1200 mg.
DK01928870T 2000-04-28 2001-04-26 Formulations and tablets for delayed release of guaifenesin DK1276467T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/559,542 US6372252B1 (en) 2000-04-28 2000-04-28 Guaifenesin sustained release formulation and tablets
PCT/US2001/013379 WO2001082895A2 (en) 2000-04-28 2001-04-26 Guaifenesin sustained release formulation and tablets

Publications (1)

Publication Number Publication Date
DK1276467T3 true DK1276467T3 (en) 2008-08-04

Family

ID=24233984

Family Applications (1)

Application Number Title Priority Date Filing Date
DK01928870T DK1276467T3 (en) 2000-04-28 2001-04-26 Formulations and tablets for delayed release of guaifenesin

Country Status (17)

Country Link
US (1) US6372252B1 (en)
EP (2) EP1913937A1 (en)
JP (1) JP2003531849A (en)
AT (1) ATE391494T1 (en)
AU (2) AU2001255680B2 (en)
CA (1) CA2405031C (en)
CY (1) CY1108166T1 (en)
DE (1) DE60133538T2 (en)
DK (1) DK1276467T3 (en)
ES (1) ES2301537T3 (en)
HK (1) HK1052651A1 (en)
IL (3) IL152012A0 (en)
MX (1) MXPA02010556A (en)
NZ (1) NZ521959A (en)
PT (1) PT1276467E (en)
TW (2) TWI314866B (en)
WO (1) WO2001082895A2 (en)

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US8012504B2 (en) * 2000-04-28 2011-09-06 Reckitt Benckiser Inc. Sustained release of guaifenesin combination drugs
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US7838032B2 (en) * 2000-04-28 2010-11-23 Reckitt Benckiser Inc. Sustained release of guaifenesin
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US20030012820A1 (en) * 2001-06-12 2003-01-16 Upadhyay Ajay Hasmukhlal Compressible guaifenesin compositions, method for making same and method for making compressed guaifenesin dosage forms therefrom
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JP2005528383A (en) * 2002-04-10 2005-09-22 ミラー，フレッド，エイチ． Multiphase, multiple compartment capsule system
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US7807197B2 (en) * 2002-09-28 2010-10-05 Mcneil-Ppc, Inc. Composite dosage forms having an inlaid portion
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Also Published As

Publication number Publication date
AU2001255680B2 (en) 2006-02-16
IL190742A0 (en) 2008-11-03
EP1276467B1 (en) 2008-04-09
TWI326602B (en) 2010-07-01
CA2405031A1 (en) 2001-11-08
DE60133538D1 (en) 2008-05-21
CY1108166T1 (en) 2014-02-12
EP1276467A2 (en) 2003-01-22
TW200727919A (en) 2007-08-01
ATE391494T1 (en) 2008-04-15
MXPA02010556A (en) 2003-10-14
IL152012A (en) 2010-04-15
ES2301537T3 (en) 2008-07-01
AU5568001A (en) 2001-11-12
PT1276467E (en) 2008-05-15
WO2001082895A3 (en) 2002-05-23
HK1052651A1 (en) 2003-09-26
NZ521959A (en) 2004-10-29
EP1913937A1 (en) 2008-04-23
WO2001082895A2 (en) 2001-11-08
CA2405031C (en) 2011-12-06
DE60133538T2 (en) 2009-07-09
JP2003531849A (en) 2003-10-28
US6372252B1 (en) 2002-04-16
TWI314866B (en) 2009-09-21
IL152012A0 (en) 2003-04-10

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